| CTRI Number |
CTRI/2019/12/022262 [Registered on: 05/12/2019] Trial Registered Prospectively |
| Last Modified On: |
02/12/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Medical Device |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
To compare the efficacy in control of pain and functional improvement of hip joint in pulsed radiofrequency ablation of articular branches of obturator and femoral nerves versus intra-articular steroid injection in management of chronic hip pain in osteoarthritis of hip. |
|
Scientific Title of Study
|
Comparison between pulsed radiofrequency ablation of articular branches of obturator and femoral nerves and intra-articular steroid injection in management of chronic hip pain in osteoarthritis of hip: A randomised controlled study. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Tasso Opo |
| Designation |
post-graduate trainee |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Physical Medicine and Rehabilitation
Regional Institute of Medical Sciences
Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
08730068455 |
| Fax |
|
| Email |
tasssopo83@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Akoijam Joy Singh |
| Designation |
Head of Department |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Physical Medicine and Rehabilitation
Regional Institute of Medical Sciences
Imphal
Regional institute of medical sciences, Lamphelpat, Imphal west, Manipur
Imphal West
MANIPUR
795004
India |
| Phone |
09436026960 |
| Fax |
|
| Email |
joyakoijam2@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Tasso Opo |
| Designation |
post-graduate trainee |
| Affiliation |
Regional Institute of Medical Sciences, Imphal, Manipur |
| Address |
Department of Physical Medicine and Rehabilitation
Regional Institute of Medical Sciences
Imphal
Imphal West
MANIPUR
795004
India |
| Phone |
08730068455 |
| Fax |
|
| Email |
tasssopo83@gmail.com |
|
|
Source of Monetary or Material Support
|
| Regional institute of medical sciences, Imphal
Manipur |
|
|
Primary Sponsor
|
| Name |
department of Physical Medicine and Rehabilitation |
| Address |
Regional Institute of Medical Sciences, imphal manipur
Imphal, Manipur |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Tasso Opo |
Regional institute of medical sciences |
Department of Physical Medicine and Rehabilitation
Imphal West
MANIPUR |
08730068455
tasssopo83@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Research Ethics Board, RIMS, Imphal |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: M169||Osteoarthritis of hip, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Intra-articular injection |
One dose of Inra-articular Methyl prednisolone 80 mg in hip joint |
| Intervention |
Radiofrequency ablation |
One sitting of two pulsed radiofrequency cycle of 180 seconds will be used for ablation of articular branches of obturator and femoral nerves of hip joint |
|
|
Inclusion Criteria
|
| Age From |
40.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with chronic hip pain for more than 6 months attending the out-patient department (OPD) of Physical Medicine and Rehabilitation, Regional Institute of Medical Sciences, Imphal |
|
| ExclusionCriteria |
| Details |
Infection of the joint
Patients with pelvic tumour
Coagulopathy
Impaired cognition
Pregnancy
Distorted anatomy
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
1)pain control measured by Visual analogue score (VAS)
2)Functional improvement assessment by Western Ontario and Mcmaster Universities Osteoarthritis Index(WOMAC) |
24 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)pain control measured by Visual analogue score (VAS)
2)Functional improvement assessment by Western Ontario and Mcmaster Universities Osteoarthritis Index(WOMAC) |
4 weeks and 12 weeks |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
15/12/2019 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This study is a randomised controlled trial comparing the efficacy in pain control and functional improvement in radiofrequency ablation of articular branches of femoral and obturator nerve with intra-articular hip steroid injection in chronic hip pain due to osteoarthritis of hip. This study shall be done in department of Physical Medicine and Rehabilitation, Regional institute of medical sciences, Imphal, Manipur. The outcomes will be measured using visual analogue scale (VAS) for pain and western ontario mcmaster universities osteoarthritis index (WOMAC) for functional assessment at baseline, four weeks, twelve weeks and twenty four weeks. The collected data will be analysed by SPSS 21 version. For calculation chi-square, independent t-test and ANOVA will be used and p value <0.05 will be taken as significant. |